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临床试验/CTRI/2025/11/096809
CTRI/2025/11/096809尚未招募Phase 3 4

Comparative study on the effects of two different techniques of combining dexmedetomidine and ketamine on post operative recovery time in patients undergoing oocyte retrieval: a randomised controlled pilot study

Aditi Singh1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2025年11月12日最近更新:

试验速览

阶段
Phase 3 4
状态
尚未招募
发起方
入组人数
60
试验地点
1
主要终点
To compare the post operative recovery time measured from procedure end to Modified Aldrete score more than equal to 9 at 10mis, 20 mins and 30 mins

研究概览

简要总结

In vitro fertilization is a common treatment for infertility. Ultrasound guided transvaginal follicle aspiration is the standard method for oocyte retrieval and is the most painful part of the IVF process. Adequate anesthesia is needed to reduce pain and ensure patient comfort. Total intravenous anesthesia has been shown to improve quality of recovery after short ambulatory procedures. The ideal anesthetic technique should provide good pain control, quick recovery, minimal side effects, and should not affect oocyte quality. Dexmedetomidine is an alpha 2 receptor agonist that provides sedation, analgesia, and anxiety relief without depressing respiration. It improves patient satisfaction and reduces the need for opioids but may cause bradycardia, hypotension, and limited deep sedation. Ketamine, an NMDA receptor antagonist, produces strong analgesia and preserves airway reflexes and cardiovascular stability. However, its use alone may lead to hallucinations and agitation. Combining dexmedetomidine with ketamine can balance their effects, offering effective sedation and analgesia while minimizing adverse reactions. This study is designed as a prospective randomized controlled trial to compare postoperative recovery time in patients receiving a combination of dexmedetomidine and ketamine using two different techniques during oocyte retrieval. The objective is to identify the safer and more effective method that provides optimal sedation, stable hemodynamics, minimal side effects, and faster postoperative recovery, thereby improving patient comfort and satisfaction in IVF procedures

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant Blinded

入排标准

年龄范围
18.00 Year(s) 至 40.00 Year(s)(—)
性别
Female

入选标准

  • Women undergoing elective oocyte retrieval.
  • ASA I & II patients.
  • Age between 18 years to 40 years.
  • Patients willing to provide informed consent.

排除标准

  • Patients who deny consent will not be included in the study.
  • ASA III and ASA IV.
  • Past history of allergy to dexmedetomidine and ketamine.
  • Chronic sedative and opioid use.

结局指标

主要结局

To compare the post operative recovery time measured from procedure end to Modified Aldrete score more than equal to 9 at 10mis, 20 mins and 30 mins

时间窗: To compare the post operative recovery time measured from procedure end to Modified Aldrete score more than equal to 9 at 10 mins,20 mins and 30 mins

次要结局

  • To evaluate & compare hemodynamic stability in terms of heart rate & blood pressure at various time intervals intraoperatively.(To assess pain score (VAS Score) on complete recovery, at thirty minutes & at sixty minutes from the end of the procedure.)

研究者

发起方
Aditi Singh
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Aditi Singh

Armed Forces Medical College, Pune

研究点 (1)

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